Mobile Phone in Hypertension Management

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Göteborg University

ClinicalTrials.gov Identifier:

NCT01510301

First received: January 11, 2012

Last updated: August 3, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2012

Last Updated Date

August 3, 2012

Start Date ^ICMJE

March 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adherence to antihypertensive medication [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Adherence to antihypertensive medication will be checked through a question in the cell phone and evaluation of patient´s use of antihypertensive medication will be checked from the National Prescribed Drug Register of drugs. Twenty patient-physician/nurse consultations will be audio/video-recorded at regularly scheduled appointments to obtain authentic evidence of the use of the self-reports in clinical practice. The outcomes will include blood pressure measurement, registration of self-reported symptoms and discourse analyses.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01510301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Systolic blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Change in systolic blood pressure

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Mobile Phone in Hypertension Management

Official Title ^ICMJE

Mastery and Autonomy in Management of Hypertension With a Mobile Self-report System

Brief Summary

The purpose of this study is to examine if a mobile phone-based self-report system, using the patient's own mobile phone, will improve adherence to treatment of hypertension and lead to personal involvement of the patient in the treatment.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Device: Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)

To test an electronic Patient-Reported Outcomes Measure (e-PROM) intended to assess patients' daily perceptions of symptoms and wellbeing, as well as self-measured blood pressure, treatment side-effects and medicine intake;

Explore patient interactions (learning and understanding) with an internet-reporting system providing structured feedback of e-PROM results to examine if such feedback is useful in improving adherence;
Explore patient-physician/nurse interactions to examine if structured feedback of e-PROM results serves as a useful complement to support consultations regarding treatment monitoring and adherence.

Study Arm (s)

Self-report

Intervention: Device: Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of arterial hypertension
Prescribed antihypertensive treatment
Alert and oriented
Swedish-speaking
Access to a functioning cell phone
Agreeing to regular controls at the National Prescribed Drug Register of drugs

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01510301

Other Study ID Numbers ^ICMJE

MIHM

Has Data Monitoring Committee

Yes

Responsible Party

Göteborg University

Study Sponsor ^ICMJE

Göteborg University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Karin I Kjellgren, professor

Göteborg University

Information Provided By

Göteborg University

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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